Device product
Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.
Z-0581-2015
Product summary
- Firm
- ConforMIS, Inc.
- Event
- Event 69867
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0581-2015
Official wording
Reason: Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting
Code information: Serial Number: 0340552
Distribution pattern: Distributed to IN.
Derived failure modes
-
Unknown
Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting